The following data is part of a premarket notification filed by Comfort Rubber Gloves Industries Sdn. Bhd. with the FDA for Black Colored Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs And Fentanyl Citrate.
| Device ID | K200181 |
| 510k Number | K200181 |
| Device Name: | Black Colored Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs And Fentanyl Citrate |
| Classification | Polymer Patient Examination Glove |
| Applicant | Comfort Rubber Gloves Industries Sdn. Bhd. Lot 821, Jalan Matang Matang, MY 34750 |
| Contact | Ng Kok Howe |
| Correspondent | Ng Kok Howe Comfort Rubber Gloves Industries Sdn. Bhd. Lot 821, Jalan Matang Matang, MY 34750 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-01-24 |
| Decision Date | 2020-04-15 |